FDA considering petition to protect biologic medications’ patents

The opening salvo fired by Abbott Laboratories could be the start of an interesting legal battle between pharmaceutical companies and generic manufacturers over biologic medications—medicines such as insulin or vaccines that are created through biological processes, not chemical synthesis.

Historically, when generic manufacturers made copycat or biosimilar versions of a biologic after its patent was up, they would have to go through the same safety and efficacy review with the Food and Drug Administration (FDA) as the makers of the original biologics. But the 2010 Biologics Price Competition and Innovation Act (BPCIA) removed that requirement, allowing biosimilars to skip safety and efficacy review, as generic non-biologic drugs are allowed to do.

Abbott petitioned the FDA last year, asking it not to apply the BPCIA to any biologics that were approved before the act passed. Abbott is seeking to protect its patents on rheumatoid arthritis treatment Humira, which will expire in 2016. The company argued that it would be unconstitutional to apply the law to Humira because the data Abbott gave to the FDA for approval counts as intellectual property. Though there have been no applications to make a biosimilar version of Humira yet, Abbott claims if there were, the FDA would use the data it provided on Humira to approve the biosimilar. This would amount to the government taking Abbott’s property without compensating it, the company argues, which is prohibited under the Fifth Amendment’s takings clause.

The FDA has yet to decide on the petition, but the agency had received 51 requests to hold a meeting to discuss biosimilars as of mid-March, and has held 38 of those meetings. The FDA is expected to release additional guidelines on biosimilars at some point, Thomson Reuters reports, though there is no indication of when that might be.